| CTRI Number |
CTRI/2024/07/071149 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Knowledge attitude and practice] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation for the efficacy of class-based intervention through jigsaw technique as against peer tutoring for improving KAP (knowledge, attitude and practice) related to menstrual hygiene and related problems among adolescent girls. |
|
Scientific Title of Study
|
comparative evaluation of the efficacy of class-based intervention through jigsaw technique as against peer tutoring for improving KAP (knowledge, attitude, and practice) related to menstrual hygiene and related problems among adolescent girls in selected school |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana Bhushan Joshi |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing, Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
490001
India |
| Phone |
9604726744 |
| Fax |
|
| Email |
verma.kalpana201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate professor |
| Affiliation |
(DMIMS) Datta Meghe Institute of Medical Science |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing, Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate professor |
| Affiliation |
(DMIMS) Datta Meghe Institute of Medical Science |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing, Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. Radhikabai Meghe Memorial College Of Nursing, DMIHER Edu, Sawangi(Meghe), Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education & Research |
| Address |
Sawangi
Wardha-442107
Maharashtra India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe Institute of Higher Education Research |
Sawangi
Wardha-442107
Maharashtra India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deeplata Mendhe |
Smt. Radhikabai Meghe Memorial college of Nursing, Sawangi,Wardha |
Room Number 3 Department of Community Health Nursing, Smt. Radhikabai Meghe Memorial College of Nursing, Datta Meghe Institute of Higher Education and Research, Wardha.
Wardha
MAHARASHTRA |
9527538397
mendhedeeplata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent girls 13-16 years |
| Patients |
, (1) ICD-10 Condition: Z848||Family history of other specifiedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing Class-Based Jigsaw Technique and Peer Tutoring Interventions |
Adolescent girls aged 10-14 are divided into Jigsaw and Peer Tutoring groups for a menstrual hygiene intervention, with pre- and post-tests to evaluate effectiveness over three months. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls age up to 13- 16 years.
Willing to participate.
Those who attend menarche.
|
|
| ExclusionCriteria |
| Details |
Adolescent girls suffering from chronic disease.
Adolescent girls who are suffering from mental disorders.
not attended menarche.
Not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved knowledge, attitude and practice.
reduced menstrual cycle associated problems.
|
Three months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : Reduction of menstrual cycle related minor problems (body pain, backache, headache, vomiting, dysmenorrhea, anaemia, mood changes, sleep disorder, itching, and redness). |
three months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, active-controlled single-blind trial, two parallel arm intervention prospective study. trial comparing the zigsaw technique and peer tutoring technique on menstrual hygiene among adolescent girls (13-16 years)f for three months follow up.data collected in selected rural schools and sample size is 240 girls (120 zigsaw group and 120 peer tutoring group). primary outcome measure by modified standarized knowledge questionairre, check list and attitude scale. and secondary outcome measure by before and after intervention check list. |